BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3992366 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01108
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE PASSED FUNCTIONAL TESTING AND DURATION TESTING, NO FAILURE FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE PASSED FUNCTIONAL TESTING AND DURATION TESTING, NO FAILURE FOUND. A NEW BATTERY WAS INSTALLED AND THE DEVICE WAS TURNED ON FOR A LONG TERM TEST. CONFIRMED THAT THE DEVICE DID NOT SHUTDOWN ITSELF DURING THE DURATION TEST AND FUNCTIONS APPROPRIATELY. SINCE NO FAILURE WAS FOUND, NO PARTS WERE REPLACED. THE DEVICE WAS CALIBRATED AND THE CIRCUIT BOARD WAS CLEANED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE EXTERNAL PULSE GENERATOR (EPG) WAS IN USE ON A PATIENT, THE DEVICE SWITCHED OFF. THIS ALSO OCCURRED AFTER THE BATTERY WAS CHANGED. IT WAS REQUESTED THAT THE EPG BE INSPECTED. THE EPG WAS RETURNED TO THE MANUFACTURER FOR SERVICING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468769 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention